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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part2:Validationrequirementsforforming,sealingandassemblyprocesses
【原文标准名称】:终端无菌医学设备的包装.第2部分:组成、密封和装配过程的确认要求
【标准号】:ISO11607-2-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-04
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;设计;可处置的;成形;作标记;材料规范;医疗产品;包装件;包装材料;性能;物理试验;公共卫生;合格;质量;质量保证;重新使用;抽样方法;密封;成型;规范;规范(验收);消毒阻挡系统;无菌;试验;证实;外观检查(试验)
【英文主题词】:Definitions;Design;Disposables;Forming;Marking;Materialsspecification;Medicaldevices;Medicalproducts;Packages;Packagingmaterial;Performance;Physicaltesting;Publichealth;Qualifications;Quality;Qualityassurance;Reuse;Samplingmethods;Sealing;Shaping;Specification;Specification(approval);Sterilebarriersystems;Sterility;Testing;Validation;Visualinspection(testing)
【摘要】:ThispartofISO11607specifiestherequirementsfordevelopmentandvalidationofprocessesforpackagingmedicaldevicesthatareterminallysterilized.Theseprocessesincludeforming,sealing,andassemblyofpreformedsterilebarriersystems,sterilebarriersystemsandpackagingsystems.ThispartofISO11607isapplicabletoindustry,tohealthcarefacilities,andwherevermedicaldevicesarepackagedandsterilized.ThispartofISO11607doesnotcoverallrequirementsforpackagingmedicaldevicesthataremanufacturedaseptically.Additionalrequirementsmayalsobenecessaryfordrug/devicecombinations.
【中国标准分类号】:C30
【国际标准分类号】:11_080_30
【页数】:11P;A4
【正文语种】:英语